Standardization News

The COVID-19 pandemic has reminded the world of the effectiveness of personal protective equipment (PPE) in reducing the spread of respiratory pathogens. The crisis has also reinforced the need for global access to PPE. In the early months of the COVID-19 pandemic, the World Health Organization (WHO) and Médicens sans Frontìres reported that PPE shortages and price hikes had left frontline workers without surgical masks, respirators, and gloves to wear when caring for highly infectious coronavirus patients. A standard approach for how to manufacture, distribute, and dispose of these garments safely was also missing. Although these deficits affected everyone, developing countries experienced the greatest effects.

In an effort to remedy these issues, the World Bank’s International Finance Corporation (IFC) launched a $4 billion financing platform in July 2020 to increase PPE production and access in emerging nations. It also approached ASTM International about sharing its PPE compliance requirements and standards on a global scale. In March 2021, the IFC and ASTM signed a memorandum of understanding (MoU) around global PPE. The MoU focused on two primary objectives: Raising awareness of medical and non-medical PPE standards and requirements; and assisting in the adoption of international PPE standards in specific countries.

The IFC and ASTM intend to reach these targets by developing and disseminating educational materials on PPE, utilizing ASTM’s existing agreements with other standards organizations, and creating cooperative agreements with the newly formed Global Collaboration Forum for Personal Protective Equipment.

FOR YOU: PPE Efforts Accelerate

As part of this MoU, ASTM launched the Global Collaboration Forum in 2021. Open to all, the biannual forum brings together manufacturers and other parties involved with the production and distribution of PPE. The initial, March 2021 webinar covered challenges facing PPE standards development, the value of global cooperation, and the role that ASTM continues to play in developing PPE standards. The event coincided with ASTM’s release of the in-depth report “Global Collaboration to Advance Personal Protective Equipment (PPE) Safety, Quality, and Innovation.”

“The forum was created in response to the pandemic and the tremendous number of inquiries from individuals and companies wanting to help with the shortages and become involved in the manufacturing of PPE,” says Dan Smith, vice president of ASTM’s technical committee operations. “Since ASTM already had many standards for PPE, to help with these inquiries, ASTM set up a microsite and provided standards related to PPE for free. For technical questions, we relied on our expert committee members to assist with answers. This led to creating an open forum where we could invite people to ask questions, engage in the discussion about industry needs, and talk about new ASTM initiatives.”

As Smith indicates, ASTM is a forerunner in global PPE standards. In February 2021, the U.S. Centers for Disease Control and Prevention (CDC) approved ASTM’s standard specification for barrier face coverings (F3502). Written by the committee on personal protective clothing and equipment (F23), the standard established minimum design, performance testing, labeling, user instruction, reporting and classification, and conformity-assessment requirements for barrier face coverings. The standard pertains to both single-use (disposable) and multiple-use coverings. The World Health Organization (WHO) also recommends wearing reusable, non-medical masks that comply with F3502 or disposable medical masks that subscribe to ASTM’s standard specification for performance of materials used in medical face masks (F2100).

Global involvement with PPE

Because it holds MoUs with 121 countries and regional bodies from the Middle East to Southeast Asia, ASTM reaches a broad audience with its PPE forum. Jordan is among more than 30 countries participating in these webinars.

“Prior to the forum, we had been engaged with the IFC on a global advisory project for PPE,” says Dr. Ruba Althawabeia. Althawabeia is the acting director of Verification, Notification, and Anti-Counterfeiting Unit at the Jordan Standards and Metrology Organization (JSMO). She was also part of a standards expert program with ASTM. “We have also had a long, distinguished relationship with ASTM. During the pandemic, Jordan had problems with all PPE items. We do not have a strong infrastructure regarding testing and standards, specifically for face masks. We need a stronger position on this issue and have adopted some standards, including the face coverings standard [F3502], so that we can continue
to improve.”

Along with improving its testing facilities, Jordan launched other PPE initiatives, including the creation of a mask manufacturing facility in the country. According to Althawabeia, these efforts have been supported by a variety of different entities, including ASTM.   

Vietnam is also considering the adoption of ASTM’s barrier face coverings standard. A long-time producer of PPE, the country donated 550,000 masks to five European countries—France, Germany, Spain, Italy, and Great Britain—and gave 390,000 to Cambodia and 340,000 to Laos in April 2020. It also expedited a shipment of over 450,000 protective suits for healthcare providers in the United States.

The Global Forum on PPE has brought together stakeholders from 30 countries.

According to Teresa Cendrowska, vice president of global cooperation at ASTM, Vietnam would like to use the forum to discuss the sustainability and disposal of PPE. “With the forum, ASTM has the potential to start addressing other issues that countries are observing and experiencing,”
she says.

Single-Use PPE and Sustainability

When it comes to PPE, sustainability is a challenge that every country faces. A major hurdle is that, because PPE is plastic-based and intended for single-use only, it creates more plastic medical waste. A November 2021 study published by the Proceedings of the National Academy of Sciences showed that, as of August 2021, over 8.4 million tons of COVID-19-related plastic waste, including PPE such as face shields, masks, and gloves, had been created. Of that amount, more than 25,000 tons had ended up in oceans. Numerous cases of marine wildlife becoming entangled, entrapped, and injured, or ingesting and dying from PPE waste have been reported.

In addition to negatively affecting wildlife, PPE waste impedes the achievement of several of the United Nations’ Sustainable Development Goals (SDG). Among the SDGs impacted by PPE waste are clean water and sanitation (SDG 6), responsible consumption and production (SDG 12), and climate action (SDG 13).

One way to ease some of these sustainability concerns would be for people to dispose of PPE properly. This could be as simple as placing the used materials in a waste receptacle. Another possible remedy is to sanitize and reuse the items. Whether PPE can be washed and safely reused has yet to be clearly established.

“It’s a tough issue for industry to not compromise the performance of the PPE in order to make it sustainable,” Smith says. He notes that committees such as the committee on sustainability (E60) are beginning to consider PPE sustainability.

One Size Does Not Fit All

Along with sustainability, the question of how well PPE fits has been raised.

“The world doesn’t develop masks that take into consideration different sizes and shapes of faces. There aren’t masks made for women, children, and different ethnicities. Everyone is expected to be able to wear the same fit. This is one of the critical issues,” Smith says. He adds that the committee on personal protective clothing and equipment is looking at fit in terms of gender and in the future might look further at age, geography, demographics, and more.

Another aspect of mask fit relates to the mask’s intended use. In other words, what does the individual wish to gain from wearing a particular mask?

“At the last webinar, a representative from OSHA [U.S. Occupational Safety and Health Administration] suggested that surgical masks, which generally have pleats and are rectangular
in shape, do not work as well as previously thought,” says Jeff Stull, president of International Personnel Protection, Inc. and a member of F23. “They have good quality filtration materials, but the original intent of that product was to capture potential infectious materials coming from the healthcare provider and going to the patient. They are meant to protect the patient, not the healthcare worker. They don’t seal against the face and consequently have gaps on many wearers where exhaled breath can leak around the side of other parts of the mask. During the webinar it was proposed that a hybrid between ASTM’s face covering and surgical mask standards be considered to address this limitation.”

Also at this event, scientists from North Carolina State University shared research related to OSHA’s presentation that quantified leakage for different types of respirators, medical masks, and face coverings using an animatronic head form. Stull says the information proved to be very helpful.

OSHA does have a mandatory fit test for face coverings. Testing determines whether a mask or respirator fits comfortably without slipping and or being too tight. According to OSHA-accepted fit test protocols, the face covering should allow for the use of eye protection and other PPE. It should also fit properly over the nose bridge and around the chin and afford the wearer enough room to talk and breathe freely.

Other Considerations

When it comes to having the right quantity and type of PPE for current and future global health crises, Stull says that many countries still don’t have all the necessary standards in place.

“There is a desire to create a set of standards for infectious diseases as whole, which makes a lot of sense. Now would be a great time to do this. We need to have better preparedness and awareness for healthcare facilities, hospitals, emergency response groups, nursing homes, and other places. If the appropriate regulatory get involved, the enforcement of compliance with PPE standards will make for a better, safer workplace.”

READ MORE: 5 Standards for Medical Face Masks and Protective Clothing

The ability of a particular region or country to implement a standard must also be considered. Stakeholders must recognize the local needs and keep in mind that lab equipment and capabilities are not the same globally. Not everyone will have access to the same materials or instrumentation.

“Testing as it’s done in the U.S. can be prohibitively expensive,” Stull says. “There are other ways to implement standards and make them work within your region. We recommend that governments use standards to qualify local materials and make it practical within their region to perform the necessary testing.”

Get Involved

Since March 2021, ASTM has hosted three forum webinars with over 100 participants in attendance at each event. Due to the large number of attendees, these early sessions have focused more on disseminating, rather than exchanging, information. Questions have been taken, but the answers are made publicly available after
the webinars.

“Over the course of this program, participants have had the opportunity to hear from technical experts who are intimately involved with the standards,” Cendrowska says. “They have gained a better understanding of the content of the standards, testing protocols, the standards’ use in real-life applications and in regulation, and related topics.”

For information about the Global Collaboration Forum for Personal Protective Equipment and how you can participate in future webinars, please contact ASTM staff manager Mary Mikolajewski (mmikolajewski@astm.org).

Kathy Hunt is a U.S. East Coast based journalist and author.